FDA Fast Tracks Gene Therapy for Chronic Angina Patients

The Fast Track designation is supported by clinical validation for its mechanism of action in refractory angina
The Fast Track designation is supported by clinical validation for its mechanism of action in refractory angina

XyloCor Therapeutics announced that the Food and Drug Administration (FDA) has granted XC001 (AdVEGF-All6A+) a Fast Track designation for improving exercise tolerance in patients with chronic angina that is refractory to standard medical therapy and not amenable to conventional revascularization procedures such as coronary artery bypass surgery and percutaneous coronary intervention and stents.

XC001 is an investigational cardiovascular angiogenic gene therapy that promotes angiogenesis to provide arterial blood flow to myocardial regions with inadequate blood supply. This enhanced blood flow is intended to relieve myocardial ischemia, improve left ventricular performance, alleviate angina symptoms and disability, and potentially improve prognosis. 

Related Articles

Magnus Ohman, Professor of Medicine, from Duke University School of Medicine, added, “These patients have significant limitations in terms of their daily activities because of the chest pain associated with their ischemic disease and XC001 could be an important new option for them.”

The Fast Track designation is supported by scientific data and clinical validation for its mechanism of action in refractory angina. The Investigational New Drug Application (IND) is open with the FDA.

For more information visit Xylocor.com.